CMAP Refinement for Pressure Injury Prevention

NCT ID: NCT04309864

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2025-07-31

Brief Summary

For Veterans with spinal cord injury who use a wheelchair, pressure injuries related to sitting are a significant daily threat to well-being. Pressure injuries are costly to treat, negatively impact quality of life and community participation, and can be life threatening. Moving or shifting at regular intervals in the wheelchair redistributes harmful pressure and reduces risk for skin breakdown, yet these movements are a challenge to perform consistently. The challenge exists due to lack of sensation to let the individual know they need to shift their weight. Pressure mapping provides a detailed visual representation of pressure distribution and can compensate for impaired sensation. Pressure mapping feedback delivered on-demand on mobile platforms can potentially increase effectiveness in carrying out behaviors to reduce risk for pressure injury when used during clinician-delivered education to set goals and monitor progress and when used at home as a self-management strategy.

Detailed Description

Objectives: The long-term goal of this project is to improve the effectiveness of pressure injury prevention education by clinicians and self-management by Veterans with spinal cord injury (SCI) through a methodical development and testing of a mobile platform based pressure mapping system called "Comprehensive Mobile Assessment of Pressure" (CMAP). The targeted risk-reduction behavior in this project is the effective use of weight shifts when sitting in a wheelchair by improving consistency, frequency, duration, and quality of movements to redistribute pressure. CMAP provides visual cues as well as individually customizable reminders that are designed to compensate for the lack of sensation that prevents the use of natural cues to redistribute pressure, by wheelchair users. An updated CMAP system will serve two important objectives: 1) assist clinicians in assessment, individualized goal-setting, and monitoring the Veteran with SCI's progress toward pressure injury prevention behavior goals while in the hospital setting; and 2) assist clinicians with individualized setup and education of the Veteran with SCI for using the CMAP system in the home setting as a self-management strategy for pressure injury prevention.

Specific Aims: The specific aims of this study include: 1a) hardware expansion to improve functionality of the CMAP system to add a docking and charging station and use of CMAP on a smartwatch based on Veteran preferences and 1b) software expansion to enhance clinical education for pressure injury prevention education, with requirements provided by clinicians; 2) determine usability of the refined CMAP system when it is integrated into patient education for Veteran's with acute SCI during their inpatient rehabilitation stay, and 3) a determine usability and efficacy of the refined CMAP system for clinician-delivered pressure injury prevention education, followed by Veteran use of CMAP in their daily routines at home.

Study Design: This four-year study will have multiple stages and will use a mixed methods approach that includes iterative focus groups and interviews with Veterans who have SCI and with clinicians who provide pressure injury prevention education to Veterans with SCI; self-efficacy and usability surveys for both Veterans and clinicians; pilot testing of CMAP during inpatient rehabilitation and testing during outpatient visits. Repeated measures will be used to evaluate changes within subject for completion of weight shifts while using CMAP, compared to periods when not using CMAP.

Methods: During the first two years, improvements to CMAP hardware and software will be guided by experience-based design guided requirements learned about through iterative focus groups including Veterans with SCI/D (n=10) and clinicians (n=10). Usability will be measured at each iteration of development using the System Usability Scale (SUS) and the User Experience Questionnaire (UEQ). The focus groups will be repeated to ensure alignment between development progress and the requirements identified by the focus groups. During the inpatient pilot test, clinician (n=3) and Veteran (n=6) self-efficacy will be measured. Veterans will complete selected sub-scales from the Skin Care Belief Scale and clinicians will answer survey questions developed specifically around providing education for performing weight shifts effectively. Veteran progress toward weight shift goals will be measured through performance monitoring within the CMAP app; Actual performance will be assessed against the individualized goals set by the clinician. During the outpatient testing, Veterans (n=20) will use CMAP at home for 2 weeks after receiving education and individualized goals for weight shift performance by clinicians. While at home, trunk movements will be monitored via actigraphy to monitor weight shift frequency to compare to baseline trunk movement data, weight shift performance data within CMAP app, and finally, compared with individualized goals for performing weight shifts. Self efficacy and usability (SUS and UEQ) of the overall system in both settings will be measured.

Conditions

Pressure Ulcer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Focus group-Veteran

Veterans will inform study staff regarding desired device design refinements

Group Type: NO_INTERVENTION

No interventions assigned to this group

Focus group-Clinicians

Clinicians will inform study staff regarding desired app design changes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Usability-inpatients

Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation.

Group Type: OTHER

Use of CMAP app for education (in-hospital)

Intervention Type: DEVICE

Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation.

Usability-in-home

The Veteran will use the CMAP system at home for two weeks to use in their daily routines, along with wearing the acti-graph one week prior, two weeks during and one week after CMAP usage.

Group Type: OTHER

Use of CMAP app (in-home)

Intervention Type: DEVICE

The Veteran will use the CMAP system at home for two weeks during their daily routines.

Interventions

Use of CMAP app for education (in-hospital)

Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation.

Intervention Type: DEVICE

Use of CMAP app (in-home)

The Veteran will use the CMAP system at home for two weeks during their daily routines.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

For Aim 1a:

• Veteran adults aged 18-80
• male and female
• with a spinal cord injury (C4 and below) or spinal cord disorder with impaired sensory function and a wheelchair user for at least one year

For Aim 2: Veteran adults aged 18-80, male and female, with a recent spinal cord injury (C4 and below) or a spinal cord disorder with impaired sensory function, who are currently in inpatient rehabilitation with at least 1 week prior to discharge. Participants must demonstrate ability to access the CMAP system application on a mobile phone or tablet independently.

For Aim 3:

• Veteran adults aged 18-80
• male and female
• manual or power wheelchair users
• at least one year post SCI onset
• (C4 and below) or a spinal cord disorder with impaired sensory function
• who are visiting the MVAHCS SCI/D Center for their annual visit or at end of a non-pressure injury stay in the hospital
• at which time review of pressure injury prevention and assessment of wheelchair seating are routinely conducted by clinicians
• Veterans using the CMAP system must demonstrate ability to access the CMAP app on a mobile phone or tablet independently

• Clinicians (SCI/D Physical and Occupational Therapists and Nurses and Ancillary Clinician) who, in their normal scope of work, provide patient education for pressure injury prevention

Exclusion Criteria

For Aim 1a:

• Any Veteran with SCI/D who is unable to verbally and cognitively communicate with the study team

For Aims 2, and 3:

• Any Veteran with SCI/D who has an active pressure injury that contacts their seating system or within six months of a flap surgery
• Any Veteran with SCI/D who is unable to verbally and cognitively communicate with the study team
• Any Veteran whose seat cushion is a customized immersion style

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Byron W Eddy

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Christine M. Olney, BSN MS PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

B3222-R

Identifier Type: -

Identifier Source: org_study_id